Identity
- Trade Name
- EcoGel 200 FDA UDI
- Generic Name
- Skin topical coupling gel FDA UDI
- Device Name
- Clear 20g Packet FDA UDI
- Model / Reference
- 40JSPC FDA UDI
- Description
- Clear 20g Packet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00628055650676 FDA UDI
- 510(k) Number
- K955246 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Skin topical coupling gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skin topical coupling gel
EcoGel 200 by Eco-Med Pharmaceutical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K955246 also covers:
- EcoGel 200 — Eco-Med Pharmaceutical Inc
- EcoGel 200 — Eco-Med Pharmaceutical Inc
- EcoGel 200 — Eco-Med Pharmaceutical Inc
- EcoGel 200 — Eco-Med Pharmaceutical Inc
- EcoGel 200 — Eco-Med Pharmaceutical Inc
- EcoGel 200 — Eco-Med Pharmaceutical Inc
- EcoGel 200 Clear — Eco-Med Pharmaceutical Inc
- Ecogel 200 — Eco-Med Pharmaceutical Inc
- Ecogel 200 — Eco-Med Pharmaceutical Inc
- Ecogel 200 — Eco-Med Pharmaceutical Inc
- Ecogel 200 — Eco-Med Pharmaceutical Inc
- Ecogel 200 — Eco-Med Pharmaceutical Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Eco-Med Pharmaceutical Inc
Sources (1)
- FDA UDI 5d36d3cc-d6c8-4620-8b40-89ed3032a530 34 fields · synced Jun 8, 2026